Tumor Infiltrating Lymphocyte Therapy for Cancer

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Overseen ByThe Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for patients with gastrointestinal stromal tumors (GIST), which are cancers in the digestive tract that have spread, returned, or cannot be surgically removed. The treatment uses specialized immune cells from the patient's own tumor to help the immune system attack the cancer. It also involves a lab-made protein called aldesleukin to boost the immune response, and patients will receive chemotherapy beforehand to prepare their bodies. The trial seeks participants whose GIST has not responded to other standard treatments or whose disease is locally advanced, recurrent, or metastatic and does not improve with surgery. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Tumor Infiltrating Lymphocyte (TIL) therapy could be promising for cancer treatment. Studies have found that TIL therapy is generally well-tolerated. For instance, one study noted that interleukin-2 (IL-2), used with TILs, was tolerated, with patients usually receiving five doses without any deaths in the first 30 days. However, some serious side effects were reported, mainly due to the chemotherapy given before TIL therapy, not the TILs themselves.

TIL therapy has been successfully used in cancers like melanoma and breast cancer, suggesting it might be safe for other cancers too. The treatment is personalized, using a patient's own cells, which may reduce the risk of certain immune-related side effects compared to other treatments. Overall, while there are some risks, research indicates that many patients tolerate TIL therapy well.12345

Why are researchers excited about this trial's treatments?

Tumor Infiltrating Lymphocyte (TIL) Therapy is unique because it harnesses the patient's own immune cells to fight cancer, a method that differs from traditional treatments like chemotherapy and radiation, which target cancer cells more broadly. TIL therapy involves extracting immune cells from the tumor, multiplying them in the lab, and reinfusing them into the patient to enhance their natural ability to attack cancer. Researchers are excited about this treatment because it offers a more personalized approach and has shown promise in targeting tumors that are resistant to standard therapies. Additionally, the use of aldesleukin to boost the effectiveness of TILs is a novel approach that could enhance the immune response further.

What evidence suggests that Tumor Infiltrating Lymphocyte Therapy might be an effective treatment for gastrointestinal stromal tumors?

Research has shown that tumor infiltrating lymphocyte (TIL) therapy can help treat certain cancers, including advanced gastrointestinal stromal tumors (GIST). TIL therapy involves enhancing immune cells taken from a patient's own tumor to help the body fight cancer. In this trial, participants will receive TIL therapy combined with interleukin-2 (aldesleukin), a protein that boosts the immune system. Studies have found that this combination can cause tumors to shrink in some patients. This treatment uses the body's immune system to find and destroy cancer cells. Previous patients with similar conditions experienced promising results with TIL therapy, suggesting it could benefit those with advanced GIST.678910

Who Is on the Research Team?

JB

Joal Beane, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with gastrointestinal stromal tumors (GIST) that have spread, come back after treatment, or are locally advanced. Participants must be able to undergo surgery and other study procedures.

Inclusion Criteria

White blood cells ≥ 3000/mm^3
Absolute neutrophil count greater than 1000/mm^3 without filgrastim support
Hemoglobin > 8.0 g/dl
See 19 more

Exclusion Criteria

History of severe immediate hypersensitivity reaction to any agents used in this study
Patients receiving any other investigational agents
Documented forced expiratory volume in 1 second (FEV1) ≤ 60% predicted in patients with prolonged cigarette smoking history (≥ 20 pack-years within past 2 years) or symptoms of respiratory dysfunction
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Chemotherapy

Patients receive cyclophosphamide and fludarabine intravenously to prepare for TIL infusion

7 days
Daily visits (in-person)

TIL and Aldesleukin Treatment

Patients receive TIL infusion followed by aldesleukin IV every 8 hours for up to 6 doses

4 days
Continuous monitoring (in-patient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
4-6 weeks, 12 weeks, every 3 months for 3 visits, then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Aldesleukin
  • Cyclophosphamide
  • Filgrastim
  • Fludarabine
  • Tumor Infiltrating Lymphocyte Therapy

Trial Overview

The study tests using a patient's own immune cells (TILs), grown from their tumor, combined with interleukin-2 (aldesleukin). Before this, patients get chemotherapy to prepare the body. The goal is to see if this approach helps fight GIST.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (TIL, aldesleukin)Experimental Treatment13 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joal Beane

Lead Sponsor

Citations

1.

en.wikipedia.org

en.wikipedia.org/wiki/Data

Data

Data is a collection of discrete or continuous values that conveys information, describing the quantity, quality, fact, statistics, other basic units of ...

Data | Open Access Journal

The dataset comprises both raw and quality-controlled genotypic data, as well as phenotypic data in structured format. ... Normative results demonstrate high ...

3.

data.org

data.org/

data.org - Data and AI for mission

From case studies to datasets. Finverse offers you proven and practical approaches to drive impact.

4.

data.gov

data.gov/

Data.gov Home - Data.gov

Here you will find data, tools, and resources to conduct research, develop web and mobile applications, design data visualizations, and more.

5.

data.ai

data.ai/

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Login | data.ai. Sign in with SSO Forgot Password? Create an account with English © 2026 data.ai, a Sensor Tower companyTerms of

Safety and efficacy of combined treatment with tumor ... - PMC

The study demonstrates good tolerability and preliminary efficacy. Keywords: tumor-infiltrating lymphocytes, TIL therapy, oncolytic virus ...

Safety and Efficacy of Tumor-Infiltrating Lymphocyte ...

IL-2 was tolerated with a median of 5 doses and no 30-day deaths. • Response rates were comparable to those with standard lymphodepletion regimens.

Tumor infiltrating lymphocyte (TIL) therapy for treating ...

“TIL therapy has been applied successfully in patients with metastatic melanoma, breast cancer, ovarian cancer, cervical cancer, ...

Safety of adoptive therapy with tumor-infiltrating ...

Our primary endpoint was severe adverse events (AEs) of grade 3 or higher. AEs were reported, reported toxicities mainly arising from NMA-LD chemotherapy and ...

Regenerative Medicine - TIL therapy

Specifically, the response rate for TIL therapy in malignant melanoma is approximately 70%, and the complete response rate, where lesions completely disappear, ...